Uterine Fibroids (Myomas or Leiomyomas) Uterine Fibroids

Uterine Fibroids (Myomas or Leiomyomas)
 Smooth muscle tumor of
the uterus
 Noncancerous
 Incidence 70%*
 Most common indication
for hysterectomy
 Causes: genetic,
hormone
New treatments for common gynecologic problems
Sarah Williams, M.D.
Boulder Women’s Care
303-441-0587
*ACOG Practice Bulletin Number 96, 2008
da Vinci Gynecology
da Vinci Gynecology
Uterine Fibroids (Myomas or Leiomyomas)
Uterine Fibroids (Myomas or Leiomyomas)
 Alternatives to Surgery
 Sxs
 Pelvic Pain
 Bleeding ->Iron def
Anemia
 Bladder Frequency,
Urgency
 Back Pain
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Watchful waiting
NSAIDs
Levonorgestrol IUD->may stop bleeding, higher expulsion
Estrogen/Progestin- first line-may control bleeding without
stimulating growth, however studies are mixed and progestins
may lead to increased growth*,**
*Wallach EE, Vlahos NF. Uterine myomas: an overview of development, clinical features, and management.
Obstet Gynecol 2004;104:393–406. (Level III)
**Venkatachalam S, Bagratee JS, Moodley J. Medical management of uterine fibroids with medroxyprogesterone acetate
(Depo Provera): a pilot study. J Obstet Gynaecol 2004;24:798–800. (Level III)
*ACOG Practice Bulletin Number 96, 2008
da Vinci Gynecology
da Vinci Gynecology
Uterine Fibroids (Myomas or Leiomyomas)
 However, evidence-based reviews suggest that current medical
therapies tend to give only short-term relief, and the crossover
rate to surgical therapies is high*
Uterine Fibroids (Myomas or Leiomyomas)
 Gonadotropin-Releasing
Hormone Agonists
 Leuprolide Acetate
(Lupron)
*Marjoribanks J, Lethaby A, Farquhar C. Surgery versus medical therapy for heavy menstrual bleeding.
Cochrane Database of Systematic Reviews 2006, Issue 2. Art. No.: CD003855. DOI: 10.1002/14651858.CD003855.pub2.
(Level III)
 Amenorrhea
 35-65% reduction in
volume in 3 months
 Temporary-return to
pretreatment size within
several months of
cessation
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Uterine Fibroids (Myomas or Leiomyomas)
da Vinci Gynecology
Uterine Fibroids (Myomas or Leiomyomas)
 Aromatase Inhibitor
(Danazol)
 Block Ovary and
peripheral E production*
 Little data on efficacy
 Not FDA approved for
fibroids
 Leuprolide Acetate
(Lupron)
 Pseudomenopause
 Hypoestrogenism leading
to bone loss
 Add back therapy after 6
months of treatment
Olive DL, Lindheim SR, Pritts EA. Non-surgical management of leiomyoma: impact on fertility.
Curr Opin Obstet Gynecol 2004;16:239–43. (Level III)
da Vinci Gynecology
 Progeterone Modulators
(Mifipristone)
 Block Progesterone
receptors in Fibroids
 Reduces volume by 2674%
 Endo Hyperplasia w/o
atypia (14-28%)**
 Elevated Liver Enzymes
(4%)- need to monitor***
*Shozu M, Murakami K, Segawa T, Kasai T, Inoue M. Successful treatment of a symptomatic uterine leiomyoma in a
perimenopausal woman with a nonsteroidal aromatase inhibitor. Fertil Steril 2003;79:628–31. (Level III)
**Steinauer J, Pritts EA, Jackson R, Jacoby AF. Systematic review of mifepristone for the treatment of uterine leiomyomata.
Obstet Gynecol 2004;103:1331–6. (Level III)Murphy AA, Kettel LM,Morales AJ, Roberts VJ,Yen SS.
***Regression of uterine leiomyomata in response to the antiprogesterone RU 486. J Clin Endocrinol Metab 1993;76:513–7
(Level III)
da Vinci Gynecology
Uterine Fibroids (Myomas or Leiomyomas)
Uterine Fibroids (Myomas or Leiomyomas)
 Surgical Approaches
 Uterine Artery Embolization
 Polyvinyl alcohol particles
 Study of 500, 42% reduction
at 3 months
 Complication rates similar
to hysterectomy (2-4%)
 Reoperation rate 29%
 At 5 years:
 Surgical Approaches
 Robotic Myomectomy
 Robotic Hysterectomy
 Hysteroscopic resection
 Hyst 13.7%
 Myomectomy 4.4%
 Repeat Embolization 1.6%
Broder MS, Goodwin S, Chen G, Tang LJ, Costantino MM, Nguyen MH, et al.
Comparison of long-term outcomes of myomectomy and uterine artery embolization. Obstet Gynecol 2002;100:864–8.
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da Vinci Gynecology
Endometriosis
Endometriosis
 Protective
 High parity,
 increased duration of lactation,
 regular exercise (4 hours/wk)*
 Endometrium (lining of uterus)
growing outside of uterus
 Usually involves ovaries, bowel,
tissues lining pelvis
 Endometriomas thicken and
bleed with cycles, causing
scarring and adhesions
 Causes: retrograde menstruation
 Sxs Severe Pelvic Pain (often
debilitating), Infertility
 Familial**
 First degree relative 7-10 fold increased risk of developing endo
 Incidence 6% reproductive age
 38% infertililty
 71-87% chronic pelvic pain
*Signorello LB, Harlow BL, Cramer DW, Spiegelman D, Hill JA. Epidemiologic determinants of endometriosis: a hospital-based
case-control study. Ann Epidemiol 1997;7:267–741. (Level II-2)
**Malinak LR, Buttram VC Jr, Elias S, Simpson JL. Heritage aspects of endometriosis. II. Clinical characteristics of familial
endometriosis. Am J Obstet Gynecol 1980;137:332–7. (Level II-2)
Matalliotakis IM, Arici A, Cakmak H, Goumenou AG, Koumantakis G, Mahutte NG. Familial aggregation of endometriosis in the
Yale Series. Arch Gynecol Obstet 2008;278:507–11. (Level II-2)
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da Vinci Gynecology
"The limbs of soldiers are in as much danger
from the ardor of young surgeons as from the
missiles of the enemy.”
Endometriosis
Surgeon Julian John Chisholm, 1864
 Treatment:
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Ocs, Progestin IUDs, DepoProvera
Leuprolide Acetate (Lupron)
Aromatase Inhibitor (Danazol)
Pelvic Floor Physical Therapy
Conservative Surgery
Firefly
Definitive: Hysterectomy
da Vinci Gynecology
da Vinci Gynecology
da Vinci Gynecology
da Vinci Gynecology
Surgical Approaches to Gynecologic Conditions
 Open (abdominal) surgery
 Minimally invasive surgery (MIS)
 Vaginal surgery
 Conventional laparoscopic surgery
 da Vinci® Hysterectomy (robotic-assisted
surgery)
da Vinci Gynecology
da Vinci Gynecology
Conventional Open Surgery Option For Hysterectomy
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Long incision
Uterus accessed directly
Blood loss: 300 ml
Hospital stay: 3 days
Home recovery 4-6
weeks
Conventional laparoscopy
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Small incisions
Better visualization
Less blood loss
Shorter hospital stay: 1 day
Reduced risk of infection
5 small incisions
1-1.5 cm
(less than half an inch)
da Vinci Gynecology
da Vinci Gynecology
Benefits of Minimally Invasive Surgery (MIS)
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Reduced blood loss
Fewer complications
Shorter LOS
Faster recovery
Less scarring
Less risk of infection
Significantly less pain
Improved cosmesis
MIS – Laparoscopic Surgery
 Minimally invasive
surgery (MIS)
 Ability to operate
through small keyhole
incisions
 The camera and
instruments fit through
the keyhole incisions
 Better visualization than
open surgery
Circa. 1991
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Drawbacks with Conventional Laparoscopic Surgery
da Vinci Gynecology
How can we overcome these drawbacks?
 Surgeon operates from a 2D image
da Vinci® Surgical System
 Straight, rigid instruments (limited range
of motion)
 State-of-the-art
robotic technology
 3-D Visualization
 Intuitive Movement
 Improved Dexterity
 Instrument tips controlled at a distance
 Reduced dexterity, precision and control
 Unsteady camera controlled by assistant
 Dependent on assistant for surgical
support through an accessory port
 Greater surgeon fatigue
 Makes complex operations more difficult
da Vinci Gynecology
da Vinci Gynecology
Vision System
The surgeon directs the instruments
Surgeon immersed in
3D image of the
surgical field
Surgeon directs the
instrument movements
using Console controls
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Wrist and finger movement
da Vinci Gynecology
Small instruments, small incisions
 Conventional laparoscopic
instruments are rigid with
no wrists
 EndoWrist® Instrument
tips move like a human
wrist
 Allows increased dexterity
and precision
da Vinci Gynecology
 EndoWrist® Instruments
fit through dime-sized
incisions
 A wide range of
instruments are
available
da Vinci Gynecology
Most common gynecologic procedures completed
utilizing the daVinci System
Hysterectomy
Bilateral Salpingo-Oophorectomy
Myomectomy
Sacrocolpopexy
SINGLE SITE
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Worldwide Procedure Growth
da Vinci Gynecology
Enabling Minimally Invasive Surgery1
in Traditionally Open Procedures
Prostatectomy
95%
Hyst-Malignant
Hyst-Benign
88%
DA VINCI
VAGINAL
LAP
OPEN
2007
2008
2009
2010
2011
2012
2013
da Vinci Gynecology
da Vinci Gynecology
1018713-US Rev A 4/15
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da Vinci® Hysterectomy for Benign
Gynecologic Conditions
Potential Cost Offset
da Vinci Hysterectomy Minimizes TAH and Conversion Rates
All Clinical Measures ― Benign Hysterectomy
DA VINCI
LAP
Length of Stay12
OPEN
Retrospective Review of Hysterectomy: Pre-Robotic versus da Vinci
Total
Minor
Complication*12
Major
Complication*12
Readmission16
$2,68424
$13,42024
$11,08716
$3,16210
vs Open
$51
$497
$274
—
$1,396
$2,218
vs Lap
$3
$40
$172
$95
$499
$809
$99111
(per day stay)
Potential Savings
1018713-US Rev A 4/15
Cost
Conversion12
Data from Drs. Thomas Payne and Ralph Dauterive
Ochsner Clinic, Baton Rouge, LA
Pre-robotic
(n=100)
da Vinci (n=100)
Age (years)
43.5
43.2
BMI
28.8
28.8
Estimated blood loss (ml)
113
61
Hospital stay (days)
1.6
1.1
Last 25
da Vinci
TAH rate
20%
4%
0%
Conversions (subset of TAH)
9%
4%
0%
Avg uterine weight of conversions
359.5
1387.5
TAH due to adhesions
8%
0%
Operative times (skin-to-skin)
92.4
119
78.7
Source: Oral presentation by Dr. Thomas Payne at AAGL 2007.
da Vinci Gynecology
da Vinci Gynecology
da Vinci Hysterectomy
Robotically Assisted Hysterectomy in Patients With Large Uteri
Clinical data* from Dr. Payne, Ochsner Clinic, Baton Rouge, LA
Obstetrics & Gynecology, March 2010.
Practice 1
(n=80)
Practice 2
(n=79)
Practice 3
(n=55)
Practice 4
(n=25)
Practice 5
(n=17)
Total
(N=256)
Range
Ave BMI
31.1
30.6
30.5
34.7
29.9
31.1
18-61.6
Mean Uterine
Weight (g)
596.1
660.0
484.8
484.7
498.5
574.5
2503,020
Previous Surgery (%)
56.3
55.7
69.1
48.0
17.7
55.5
NA
NA
Conversion (%)
2.5
0.0
3.6
0.0
0.0
1.62
Complications (%)
1.3
7.6
1.8
4.0
0.0
3.5
NA
LOS (day)
1.1
1.2
1.0
1.0
1.4
1.1
1-11
EBL (ml)
81.4
112.3
91.9
105.0
132.4
98.9
10-800
Mean skin-to-skin
operative time (min)
123.7
193.41
148.6
138.7
125.5
151.4
40-340
1 Practice
2
 Dexterity for complex
dissections (e.g
endometriosis)
 Vaginal cuff suture closure
with ease
 Improved visualization and
access around the cervix for
a colpotomy
Video courtesy of Javier F. Magrina, M.D.
2’s operative time affected by high percentage of additional procedures, where all patients received a modified McCall’s culdoplasty during surgery.
3 of the 4 conversions due to lack of intraabdominal space because of the large size and shape of uteri.
da Vinci Gynecology
da Vinci Gynecology
The Future: Single-Site™ da Vinci®
Benefits of da Vinci Hysterectomy
 Enables GYNs to treat complex pathology endoscopically
 Unsurpassed precision, dexterity and control offer potential for:
 More precise and efficient dissections
 Ureters, vesico-uterine reflection, colpotomy
 Quicker, easier vaginal cuff closure
 Greater ability to perform MIS on more patient types
 Compromised anatomy and tissue planes, e.g., due to
endometriosis and adhesive disease from prior pelvic surgeries
 Larger pathology
 Obese patients
The Virtually Scarless Intra-Abdominal Hysterectomy
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da Vinci Gynecology
da Vinci Single-Site
Single-Site Advantage for Hysterectomy
 Robotic Surgery through a
single umbilical port
 US FDA Cholecystectomy
Clearance Dec 2011
 Benign hysterectomy /
Salpingo Oophorectomy
Clearance Feb 2013
Multi-Port fundamentals
+
da Vinci Si technology
Triangulated instruments
3DHD vision
Unobstructed view of the
surgical field
Intuitive motion
=
Safe and reproducible
single-incision
Hysterectomy
Precise movement
Remote center technology
873725 H 1/13
da Vinci Gynecology
Single‐Site™ Instrumentation has CE Mark and is FDA‐cleared for cholecystectomy.
da Vinci Gynecology
PN 875265 Rev A 11/11
Ability to manipulate up to
3 instruments
simultaneously
Endometriosis
Endometriosis
daVinci Firefly
 Fluorescence imaging +
Indocyanine Green (ICG) dye
da Vinci Gynecology
SGO Position Statement: Morcellation
da Vinci Gynecology
SGO Position Statement: Morcellation
 Patients being considered for minimally invasive
surgery performed by laparoscopic or robotic
techniques who might require intracorporeal
morcellation should be appropriately evaluated
for the possibility of coexisting uterine or cervical
malignancy. Other options to intracorporeal
morcellation include removing the uterus through
a mini-laparotomy or morcellating the uterus
inside a laparoscopic bag.
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 Uterine leiomyomas are a common indication for
power morcellation. Fewer than one out of 1000
women who undergo hysterectomy for
leiomyomas will have an underlying malignancy.
The SGO recognizes that currently there is no
reliable method to differentiate benign from
malignant leiomyomas (leiomyosarcomas or
endometrial stromal sarcomas) before they are
removed. Furthermore, these diseases offer an
extremely poor prognosis even when specimens
are removed intact.
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SGO Position Statement: Morcellation
Age > 60
AA race: Two fold higher incidence
Prolonged tamoxifen use, defined as five years or more
Pelvic Irradiation
Hereditary Leiomyomatosis and Renal Cell Carcinoma
(HLRCC) syndrome- Rare autosomal dominant syndrome.
Uterine sarcomas associated with HLRCC are often found in
younger women
 Survivors of childhood retinoblastoma -Higher risk for
sarcomas in general, including uterine sarcoma
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